A watertight container that can be connected to a sterile enclosure, including a collar to protect against potential contamination during product transfer.

Abstract

The invention relates to a leak-proof container (1) connectable to a sterile enclosure for transferring products between said container and said enclosure. The container (1) comprises a container body (2) formed of a flexible film, an opening, and a device for connecting the container (1) to the enclosure. The container body includes a container flange (4) defining the opening closed by a container door. The container flange (4) is connectable to a flange of the enclosure (11), and the container door is connectable to a door of the enclosure. The container (1) further comprises a flexible internal collar (9) capable of covering a continuous circumferential critical contamination line extending between the assembled container flange and enclosure flange when the container is connected to the enclosure and the container and enclosure doors are in the open position. Figure to be published with the abstract: Fig. 1

Description

Title of the invention: WATERPROOF CONTAINER CONNECTED TO A STERILE ENCLOSURE INCLUDING A PROTECTIVE COLLAR AGAINST POTENTIAL CONTAMINATION DURING PRODUCT TRANSFER. TECHNICAL FIELD OF THE INVENTION

[0001] The present invention relates to the field of product transfer between a sealed container and a sterile enclosure on which the container is anchored, the internal space of the container and the enclosure respectively being in communication with each other without contact with the external environment.

[0002] The invention relates more particularly to a sealed container connectable to a sterile enclosure for the transfer of products between said container and said enclosure, said enclosure comprising an enclosure flange delimiting an enclosure opening closed by an enclosure door, the container comprising a container body formed of a flexible film delimiting a receiving space and provided with an opening in the receiving space, and a container connection device to the enclosure, comprising a container flange delimiting the opening closed by a container door, the container flange being connectable to the enclosure flange and the container door being connectable to the enclosure door.

[0003] The sealed container according to the invention is intended in particular, but not exclusively, for the transfer of hazardous products such as certain pharmaceutical, biotechnological, biological, chemical or radioactive products, the transfer of components such as caps, bottles, pistons, syringes, etc., the transfer of environmental control devices such as culture media supports, particle counters, etc., the transfer of cleaning systems, the transfer of liquids, powders, tools, the transfer of waste to the outside of the enclosure and / or the transfer of any element necessary for the production or maintenance of the production line. STATE OF THE ART

[0004] In order to ensure the transfer of sterile products from one volume to another without breaking the containment, it is known to use double-door leak-proof connection devices.

[0005] These double-door connection devices are formed by a first and a second door / flange assemblies, one of the door / flange assemblies equipping the volume into which the products are to be transferred, the other door / flange assembly equipping the volume from which the products will be transferred. Such connection devices are commonly known as Beta ports when associated with a container and Alpha ports when associated with an enclosure.

[0006] The transfer of products between the container and the enclosure is carried out by mooring the container to the enclosure by connecting the Beta port of the container to the Alpha port of the enclosure, the flange of the container being connected to the flange of the enclosure and the container door being connected to the enclosure door, then proceeding to open the double door formed by the container door and the enclosure door assembled.

[0007] The seal between the flange and the door of each assembly is ensured by a sealing gasket. When the double door is open, the sealing gasket carried by the flange of port Beta ensures the seal between the two assembled flanges, while the sealing gasket carried by the door of port Alpha ensures the seal between the two assembled doors.

[0008] The flange / flange assembly seal has a critical line of potential contamination. The integrity of the seal between the two flanges may be compromised at this line due, for example, to the presence of external particles or wear of the seal. If the critical line is contaminated at both flanges, the mere passage of products through the opening and their contact with the critical line can lead to contamination of the enclosure and the transferred products.

[0009] In an attempt to overcome this problem, a sealed junction device between two enclosures was proposed in patent application EP2504101, which includes means structurally integrated into the door and / or flange capable, when the assembled doors of the two enclosures are in the open state, of forming a separation between the communication space and an annular critical line at the level of the two assembled flanges (outer critical line) and an annular critical line at the level of the two assembled doors (outer critical line), the means of protection against any contamination at the location of the critical line are in the form of an appropriately sized annular deflector structurally integrated into one of the flanges and placed between the communication space and the critical line, the latter thus being normally unreachable during passage into the communication space.

[0010] Although the joining device of the aforementioned application addresses the problem of the prior art, the integration of a rigid annular deflector into one of the flanges has the disadvantage of obstructing the passage opening. Furthermore, such integration requires a structural modification of all parts of the existing joining devices, regardless of whether the deflector is supported by one of the flanges or one of the doors, making the proposed solution expensive and difficult to adapt to existing structures.

[0011] The invention aims to remedy this problem by proposing an arrangement that limits the risk of contamination of products contained in a container during their transfer into a sterile enclosure to which the container is attached, while being simple to implement and low cost, and not requiring modification of existing junction devices. SUBJECT OF THE INVENTION

[0012] To this end, and according to a first aspect, the invention proposes a sealed container connectable to a sterile enclosure for the transfer of products between said container and said enclosure, said enclosure comprising an enclosure flange delimiting an enclosure opening closed by an enclosure door, the container comprising a container body formed of a flexible film delimiting a receiving space, an opening in the receiving space, a device for connecting the container to the enclosure, said device comprising a container flange delimiting the opening closed by a container door, the container flange being connectable to the enclosure flange and the container door being connectable to the enclosure door,The container is remarkable in that it has a flexible internal collar capable of covering a continuous circumferential critical contamination line when the container is connected to the enclosure and the container and enclosure doors, connected to each other, are in the open position.

[0013] By critical contamination line, we mean the line extending between the container flange and the enclosure flange when these are connected to each other.

[0014] Advantageously, the collar is arranged within the container so as to present a free end extending towards the opening, the opposite end defining a circumferential junction with the container body.

[0015] Advantageously, the collar is dimensioned to have a length such that the collar extends through the opening, protruding from the front plane of the container flange when the container door is in the open position.

[0016] Advantageously, the collar has a flared section in the opposite direction to the receiving space.

[0017] Advantageously, the collar and the container body are formed as a single unit.

[0018] Advantageously, the collar is a separate part of the container body showing solidarity with the latter.

[0019] Advantageously, the container body and the collar are formed from the same material.

[0020] Advantageously, the collar is made of polymer, preferably polyethylene.

[0021] Advantageously, the container includes a handling compartment for household products within the reception area.

[0022] Advantageously, the handling compartment is glove-shaped. BRIEF DESCRIPTION OF THE FIGURES

[0023] Other features and advantages of the invention will become apparent from the detailed description of the invention that follows, given by way of example and with reference to the accompanying figures in which:

[0024] [Fig.1] Fig.1 represents a partial longitudinal cross-sectional view of a sealed container according to an example of an embodiment of the invention;

[0025] [Fig.2] [Fig.2] represents a view of the container of [Fig.1] equipped with its door ;

[0026] [Fig.3] [Fig.3] represents a schematic view of the container of [Fig.1] coupled to the enclosure, the only constituent parts of which represented are the flange and the enclosure door;

[0027] [Fig. 4] Fig. 4 represents a partial longitudinal cross-sectional view of a container according to a variant embodiment of the invention;

[0028] [Fig. 5] Fig. 5 represents a partial perspective view of the container of the [Fig.4];

[0029] [Fig. 6] [Fig. 6] shows a partial view of the container of [Fig. 4] equipped with its door;

[0030] [Fig.7] Fig.7 represents a perspective view of a container according to a variant embodiment of the invention;

[0031] [Fig.8] Fig.8 represents a perspective view of a container according to another variant embodiment of the invention;

[0032] [Fig.9] Fig.9 represents a perspective view of a container according to a Another example of an embodiment of the invention is the container comprising an internal handling glove.

[0033] For clarity, identical or similar elements of the different embodiments are identified by identical reference signs throughout the figures. DETAILED DESCRIPTION OF THE INVENTION

[0034] In relation to figures 1 to 3, a sealed container 1 connectable to a sterile enclosure is described for the transfer of products between the container 1 and the sterile enclosure.

[0035] More specifically, the container 1 comprises a container body 2 formed of a flexible film delimiting a receiving space 3, an opening 8 in the receiving space 3, a container flange 4 delimiting the passage opening, and a container door 5 closing the opening 8 (Figures 1 and 2). The container flange 4 and the container door 5 are arranged to form a connection device capable of cooperating with a complementary connection interface equipping the enclosure on which Container 1 is intended to be connected. The enclosure connection interface includes an enclosure flange 11 delimiting the opening of the enclosure and an enclosure door 12 closing the opening of the enclosure (shown in [Fig.3]), container flange 4 being intended to be connected to the enclosure flange while container door 5 being intended to be connected to the enclosure door.

[0036] According to the invention, the container 1 has a flexible internal collar 9 suitable for covering the critical contamination line 10 when the container 1 is connected to the enclosure and the container and enclosure doors are assembled in the open position, the critical contaminant line extending between the container flange 4 and the enclosure flange when these are connected to each other ([Fig.3]).

[0037] The collar 9 is advantageously supported by the container body 2. In the illustrated example, the collar 9 is a separate part of the container body 2, attached to it by any means known to those skilled in the art, such as welding, without departing from the scope of the invention. In this case, and preferably, the collar 9 and the container body 2 will be made of the same material, preferably a polymer film, and advantageously polyethylene. It is understood that the collar 9 may be made of a different material than the container body 2. In this case, the materials will preferably be chosen to allow for attachment by welding.

[0038] The collar 9, internal to the container 1 and tubular in shape, has one end forming a circumferential junction 91 with the inner wall of the container body 2, the other end 90 being free. In order to ensure coverage of the critical contamination line, the collar 9 is dimensioned to have a length such that the collar 9 extends through the opening 8, which protrudes from the front plane of the container flange 4 when the latter is not closed by the container door.

[0039] Thanks to this arrangement, the collar 9 provides a means of protecting the products during their transfer from container 1 into the enclosure. Indeed, when container 1 is connected to the enclosure and the container and enclosure doors, which are joined together, are opened, the collar covers the critical contamination line. It thus forms a screen separating the critical contamination line 10 from the opening 8. Contact between the products and the critical contamination line 10 during their transfer into the enclosure is therefore avoided.

[0040] Preferably, the collar 9 has a frustoconical shape. Advantageously, the free end forms the wider base, the opposite end (end defining the joining line) forms the base of the smaller frustoconical shape.

[0041] The truncated conical shape of the collar 9, combined with its flexibility, has the advantage of providing a screen that protects products passing through the opening 8 of the critical line of contamination 10 without being forced to reduce the opening 8. Thus, together with reducing the risks of contamination of products during their transfer, the transfer of products is facilitated.

[0042] Figures 4 to 6 illustrate an alternative embodiment of the container of [Fig. 1] the invention. In this embodiment, the flange 9 is formed as a single unit with the container body 2. It is formed from a fold at the end of the container body 2, defining the passage opening 8 over a given length. The length of the fold is defined such that, once the container body 2 is mounted and fixed onto the container flange 4, the fold has a free portion extending inwards towards the container body. This free portion is then pushed back towards the passage opening 3, thus forming the flange 9.

[0043] Advantageously, the container body and the portion of the fold interposed between the wall of the container body 2 and the container flange 4 are welded onto the container flange 4. In order to ensure the mechanical strength of the weld and to reinforce the seal, a locking ring is clipped onto the flange, clamping the annular portion on the container body 2 welded onto the container flange 4.

[0044] As before, the collar 9 has a length such that in the absence of the container door 5, it extends slightly in projection from the external front plane of the container flange 4 (figures 4 and 5) while in the presence of the container door 5, the collar 9 has a slight compression ([Fig.6]).

[0045] Figure 7 illustrates another embodiment of the container of Figure 1. In this embodiment, the flange 9 is an annular piece attached to the container flange 4 by any means known to those skilled in the art (for example, by bonding). The container body 2 is then mounted on the flange, with the flange 9 extending within the container body 2, then welded to the flange, and the portion of the flange affixed to the outer circumference of the container flange 4. In Figure 7, the flange 9 and the container body 2 are shown partially. As can be understood, the flange 9 is long enough to protrude from the outer front plane of the container flange 4 so as to cover the critical contamination line 10 once the container is secured to the enclosure and the container and enclosure doors are opened.

[0046] According to an alternative embodiment, illustrated in [Fig. 8], a collar 9 may advantageously be provided with a length extending inside the enclosure. The collar 9 advantageously has a constant annular cross-section, with dimensions substantially equal to the passage opening. The advantage of such a configuration is that it prevents contact of the products with the critical contamination line 10 during their transfer, while simultaneously facilitating the transfer of the products. Thanks to the presence of a collar configured in this way, it is no longer necessary to use a discharge chute.

[0047] Figure 9 illustrates another embodiment of an AI container according to the invention. In this example, the AI ​​container retains all the characteristics of the container 1 described above. This AI container, however, also includes a handling compartment 6 located within the container body 2, in the receiving space 3. In the illustrated example, the compartment is glove-shaped. The handling glove 6 has a passage opening 7 for a user's hand, which opens at the bottom 21 of the container body 2. The bottom 21 of the container body 2 thus has a slot forming the passage opening 7 for a hand to pass into the handling glove 6.The handling glove 6 is advantageously welded to the container body 2, the passage opening 7 inside the handling glove 6 being delimited by edges welded to the edge delimiting the opening made at the bottom 21 of the container body 2, opposite the opening of container IA. .

[0048] Thanks to the presence of a handling compartment directly provided within the container itself, the transfer of products between the IA container and the sterile enclosure to which the IA container is connected is facilitated.

[0049] Like the collar 9, the handling glove 6 is made of a flexible film, advantageously made of polymer, and preferably of polyethylene.

[0050] The invention is described above by way of example. It is understood that a person skilled in the art is able to carry out different embodiments of the invention without departing from the scope of the invention.

Claims

Demands

1. A leak-proof container (1, IA) connectable to a sterile enclosure for the transfer of products between said container and said enclosure, said enclosure comprising an enclosure flange (11) defining an enclosure opening closed by an enclosure door (12), the enclosure flange (11) and the enclosure door (12) forming a connection interface, the container (1, IA) comprising: - a container body (2) formed of a flexible film defining a receiving space (3), - an opening (8) in the receiving space (3), - a device for connecting the container (1, IA) to the enclosure, comprising a container flange (4) defining the opening (8) closed by a container door (5), the container flange (4) being connectable to the enclosure flange (11) and the container door (5) being connectable to the enclosure door (12), characterized in that the container (1,IA) includes a flexible internal collar (9) capable of covering a continuous circumferential critical contamination line (10) when the container 1 is connected to the enclosure and the container and enclosure doors, connected to each other, are in the open position.

2. A sealed container (1, IA) according to claim 1, characterized in that the collar (9) is arranged within the container (1, IA) so as to present a free end (90) extending in the direction of the opening (8), the opposite end defining a circumferential junction with the container body (2).

3. Watertight container (1, IA) according to claim 1 or claim 2, characterized in that the collar (9) is dimensioned to have a length such that the collar (9) extends through the opening (8), protruding from the front plane of the container flange (4) when the container door (5) is in the open position.

4. Container (1, IA) sealed according to any one of the preceding claims, characterized in that the collar (9) has a flared cross-section in the opposite direction to the receiving space (3).

5. Watertight container (1, IA) according to any one of the preceding claims, characterized in that the collar (9) and the container body (2) are formed as a single piece.

6. Watertight container (1, IA) according to any one of claims 1 to 4, characterized in that the collar (9) is a separate part of the container body (2) attached to the latter or to the container flange (4).

7. Watertight container (1, IA) according to claim 6, characterized in that the container body (2) and the collar (9) are formed of the same material.

8. Container (1, IA) sealed according to any one of the preceding claims, characterized in that the collar (9) is made of polymer, preferably polyethylene.

9. Watertight container (1, IA) according to any one of the preceding claims, characterized in that it comprises a household product handling compartment within the receiving space (3).

10. Container (1, IA) sealed according to any one of the preceding claims, characterized in that the handling compartment has the shape of a glove.

Images